New heart guidelines may put 12.8 million more Americans on statins

CHICAGO (Reuters) - New guidelines on heart health that
sparked fierce debate among U.S. cardiologists last fall could
lead 12.8 million more Americans to take cholesterol-lowering
statin drugs, U.S. researchers said on Wednesday.

The new estimate would mean 56 million people, or nearly
half of the U.S. population between the ages of 40 to 75, could
be eligible for taking a statin to prevent heart disease. The
findings were published on Wednesday in the New England Journal
of Medicine's online edition.

Most of those would be people over age 60, according to the
new analysis, which is the first to quantify the impact of the
guidelines issued in November by the American Heart Association
and the American College of Cardiology.

The recommendations represent a major change in assessing a
person's risk for heart disease. Instead of working to lower a
patient's "bad" LDL cholesterol to specific numeric targets,
they ask doctors to embrace a new online calculator that factors
in characteristics such as smoking and obesity to predict an
individual's risk of heart disease.

Patients with a 7.5 percent or greater chance of having
heart disease within 10 years would be considered eligible for
treatment with a statin, such as Pfizer Inc's Lipitor, known
generically as atorvastatin, or AstraZeneca's Crestor.

Critics last fall said the risk calculator overestimated the
number of people in need of treatment, and many speculated it
would add tens of millions of new statin users.

Dr. Steven Nissen, a cardiologist at the Cleveland Clinic
who in November argued for a delay in implementing the
guidelines, said the new analysis reinforces some of his
concerns.

"It shows there is a huge expansion of the number of people
for whom statins are recommended," he said in a telephone
interview.

The increase is still lower than some estimates. In a blog
post on the American Board of Integrative Holistic Medicine
website on December 15, Dr. Jorge Bordenave, a cardiologist in
Coral Gables, Florida, estimated the number of new statin users
to be 31 million.

"There were a lot of opinions various experts expressed.
Some quoted really high numbers," said Michael Pencina, a
biostatistician at Duke University's Clinical Research
Institute, who led the study published on Wednesday.

NATIONAL HEALTH SURVEY

To arrive at a more precise number, Pencina's team used data
from the National Health and Nutrition Examination Surveys
(NHANES), a representative survey of the U.S. population. The
researchers focused on 3,773 participants between 40-75 who had
provided detailed medical information, including fasting
cholesterol levels from blood tests.

They compared recommendations for statin use under the new
guidelines and the prior guidelines and extrapolated that number
to the U.S. population of 115 million adults aged 40 to 75.

Based on the analysis, the new guidelines could result in 49
percent of adults in that age range being recommended for statin
therapy, an increase of 12.8 million people who would be newly
eligible for a statin recommendation, a 38 percent increase from
the older guidelines.

The increase was especially pronounced among adults over 60,
with 77 percent recommended for statin use versus 48 percent
under the prior guidelines.

That compared with an increase of between 27 percent and 30
percent among U.S. adults between the ages of 40 and 60.

The biggest impact of the change is among older healthy men
who are not on statins. Under the earlier guidelines, some 30
percent of men age 60 to 75 were recommended for statin use.
That number jumps to 87.4 percent under the new guidelines.

For healthy women over 60, the number newly recommended for
statin use jumps from 21.2 percent to 53.6 percent.

Of course, not all who are eligible for statin treatment
based on the risk calculator would get a prescription, Pencina
concedes.

Dr. Neil Stone, a professor of preventive cardiology at
Northwestern University's Feinberg School of Medicine who
chaired the committee that issued the new guidelines, said that
is precisely the point.

Stone said the risk estimator was intended to be used as a
tool to inform doctors and patients about the potential need for
treatment.

"The risk estimator doesn't determine the statin
prescription. It determines the need for a risk discussion," he
said.

Dr. Paul Ridker and Dr. Nancy Cook of Brigham and Women's
Hospital sparked controversy last fall by saying the risk
calculator was flawed. They said the new study suggests that
most of the patients newly eligible for statins will be older
adults who smoke or have high blood pressure, but not high
cholesterol.

"As the new guidelines correctly suggest, before initiation
of statin therapy in these patients, physicians should first
have a conversation about diet and exercise, and if relevant,
smoking cessation and blood pressure control," they said in a
statement.

Although the American Heart Association has said the risk
calculator had been vetted by many experts, Nissen said it was
never published in a peer-reviewed journal.

"We are now for the first time really beginning to
understand who this risk calculator will recommend for
treatment," he said.

Until there is more clarity, Nissen believes doctors will
stick with what they know. "People are voting with their feet.
We're not using the guidelines," he said.